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Trial record 34 of 396 for:    Neuromuscular | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery

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ClinicalTrials.gov Identifier: NCT02778945
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chon Jin Young, The Catholic University of Korea

Brief Summary:

In the present study, the investigators compare intermediate and deep NMB i.e. the two extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a surgical procedure which is considered to be very sensitive for inadequate muscle relaxation, elective minimally invasive spinal surgery.

The primary objective of this trial is to compare the operation time reduction with the help of the decreased stiffness of targeted back muscle surrounding the surgical field.

The changed back muscle stiffness also measured as secondary objective goal by a mechanical tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).

Other observational objectives are divided into the following categories of stakeholders: patients, surgeons and anesthesiologists', done by collecting the variety of clinical parameters. The following will be collected and compared.

  1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay, transfer rate to SICU for post-op. care, post-operative respiratory complication rate, and total hospital costs.
  2. For surgeons Post-operative complications in regard to operation field, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.
  3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.

Condition or disease Intervention/treatment Phase
Neuromuscular Block Orthopedic Disorder of Spine Muscle Weakness Drug: Rocuronium 0.9 mg/kg Drug: Rocuronium 0.6 mg/kg Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Deep Versus Moderate Neuromuscular Blockade for Optimising Surgical Conditions Include Patient Benefits During Spinal Surgery: A Randomized Controlled Double Blinded Clinical Study
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group D (Deep NMB group)
Neuromuscular block with Rocuronium 0.9 mg/kg for anesthetic induction Infusion of Rocuronium 0.3mg/kg/hr titrated to maintain a post-tetanic count (PTC)0-2 during the operation.
Drug: Rocuronium 0.9 mg/kg
Neuromuscular block with Rocuronium 0.9 mg/kg for anesthetic induction Infusion of Rocuronium 0.3mg/kg/hr titrated to maintain a post-tetanic count (PTC)0-2 during the operation.

Active Comparator: Group I (Intermediate NMB group)
Use NMB as conventional clinical usage Neuromuscular block with Rocuronium 0.6 mg/kg for anesthetic induction Intermittent bolus i.v injection of Rocuronium 0.15mg/kg for train-of-four (TOF) 1-2 during the operation
Drug: Rocuronium 0.6 mg/kg
Neuromuscular block with Rocuronium 0.6 mg/kg for anesthetic induction Intermittent bolus i.v injection of Rocuronium 0.15mg/kg for train-of-four (TOF) 1-2 during the operation




Primary Outcome Measures :
  1. the operation time [ Time Frame: Intraoperative ]

    Primary endpoint:

    To compare the measurements of the operation time reduction, the operation time should be recorded by institutional electronic medical chart from the incision to the final suture closure of surgical wound. A difference of 10% change of operation time between two groups is considered of clinically meaningful difference.



Secondary Outcome Measures :
  1. back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) ) [ Time Frame: Intraoperative ]

    1. Shear Wave Ultrasound Elastography(SWE): SWE score value will be collected 3 times as followings. First, After enrolled, the obtained informed consent for this clinical study and screening, SWE score measure will be taken prior to surgery as a basal value from the patient.

    Second, After Induction and patient positioning, measure the targeted back muscle stiffness by using ultrasonography of SWE.

    Third, SWE score measure finally after the stich out before the discharge.


  2. back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer) [ Time Frame: Intraoperative ]
    2. Mechanical Tension Weighing Scale(MTWS) of mechanical dynamometer: After surgical incision, measure the targeted back muscle stiffness by using MTWS. It will be compared between the study groups.


Other Outcome Measures:
  1. post-anesthetic care unit stay [ Time Frame: 1 hour after operation ]
    time duration during post-anesthetic care unit stay

  2. transfer rate to intensive care unit [ Time Frame: 1 hour after operation ]
  3. post-op pain score [ Time Frame: 30minutes, 6hours, 12hours, 48hours after operation ]
    post operative pain is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.

  4. post-op nausea and vomiting(PONV) [ Time Frame: 30minutes, 6hours, 12hours, 48hours after operation ]
    post operative nausea and vomiting is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.

  5. total hospital cost [ Time Frame: 4 weeks after operation ]
    calculated in KRW

  6. surgical condition [ Time Frame: Intraoperative ]
    evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively.

  7. intraoperative ventilation parameters (1. lung compliance) [ Time Frame: Intraoperative ]
    lung compliance is measured by anesthetic machine ( GE Avance)

  8. intraoperative ventilation parameters (2. peak airway pressure) [ Time Frame: Intraoperative ]
    peak pressure is measured by anesthetic machine ( GE Avance)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients had to be scheduled by the surgeons for an elective spinal surgery required correction of 1 to 3 segment level of spine under general anesthesia.
  • Patients with ASA-classification (the American Society of Anesthesiologists) physical status classed as I to II aged 19 years old and over will be enrolled.

Exclusion Criteria:

  • expected a difficult airway
  • known neuromuscular disease
  • known allergy or hypersensitivity to one of the drugs used in this study
  • intake of any medication that might interact with muscle relaxants.
  • Female subjects will be excluded if they were either pregnant, of childbearing potential, not using a mechanical method of birth control, or if they were breast-feeding.
  • subjects who are unable to understand or successfully administer a patient controlled analgesia (PCA) device,
  • subjects who are declined to participate during the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778945


Contacts
Contact: Jin Young Chon, M.D., Ph.D. 82-2-3779-1268 anestha@catholic.ac.kr
Contact: Ho Sik Moon, M.D., Ph.D. 82-2-3779-1900 mhsjshcat@catholic.ac.kr

Locations
Korea, Republic of
Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 07345
Contact: Jin Young Chon, M.D., Ph.D.    82-2-3779-1268    anestha@catholic.ac.kr   
Principal Investigator: Jin Young Chon, M.D., Ph.D.         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Chair: Jin Young Chon, M.D., Ph.D. Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital

Publications:

Responsible Party: Chon Jin Young, Professor, Department of Anesthesiology and Pain Medicine, The Catholic University of Korea, College of Medicine,, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02778945     History of Changes
Other Study ID Numbers: ANESTHA-NMB1
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chon Jin Young, The Catholic University of Korea:
spinal surgery
sugammadex
deep neuromuscular block
shear wave elastography
neuromuscular monitoring

Additional relevant MeSH terms:
Muscular Diseases
Neuromuscular Manifestations
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Muscle Weakness
Paresis
Musculoskeletal Diseases
Spinal Diseases
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Bone Diseases
Anesthetics
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Peripheral Nervous System Agents